The following data is part of a premarket notification filed by Icu Medical, Inc with the FDA for Pull Tab Squeeze Flush.
| Device ID | K070979 |
| 510k Number | K070979 |
| Device Name: | PULL TAB SQUEEZE FLUSH |
| Classification | Catheter, Continuous Flush |
| Applicant | ICU MEDICAL, INC 4455 ATHERTON DR. Salt Lake City, UT 84123 |
| Contact | Tracy Best |
| Correspondent | Tracy Best ICU MEDICAL, INC 4455 ATHERTON DR. Salt Lake City, UT 84123 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-06 |
| Decision Date | 2007-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887709088570 | K070979 | 000 |
| 10840619027787 | K070979 | 000 |